6.5CM ADULT CRANI ATTACHMT Adverse Event — Malfunction (MDR 1045834-2020-00715)
6.5CM ADULT CRANI ATTACHMT Adverse Event — Malfunction (MDR 1045834-2020-00715) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 6.5CM ADULT CRANI ATTACHMT; Generic name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC); Manufacturer: DEPUY SYNTHES PRODUCTS LLC.
| Device | 6.5CM ADULT CRANI ATTACHMT |
|---|---|
| Generic name | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Report number | 1045834-2020-00715 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: THE DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS TRACED TO COMPONENT |
| Source | openFDA MAUDE (device adverse events) |
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